Profemur R. Surgical Technique SURGICAL TECHNIQUE

Transcription

1 Profemur R Surgical Technique SURGICAL TECHNIQUE

2 Profemur R Revision System Proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training, experience and patient condition. Prior to use of the system, the surgeon should refer to the product package insert for additional warnings, precautions, indications, contraindications and adverse effects. Instructions for Use Package inserts are also available by contacting the manufacturer. Contact information can be found on the back of this surgical technique and the package insert is available on the website listed. Package inserts can be found under: Prescribing on ortho.microport.com 2

3 TABLE OF CONTENTS PREFACE DESIGN FEATURES OF THE PROFEMUR R HIP SYSTEM CHAPTER 1 PREOPERATIVE PLANNING CHAPTER 2 SURGICAL TECHNIQUE CHAPTER 3 IMPLANT REMOVAL CHAPTER 4 TECHNIQUE OVERVIEW CHAPTER 5 ORDERING INFORMATION A IMPLANTS - PROFEMUR R PROXIMAL PARTS - PROFEMUR R DISTAL STEMS - PROFEMUR R ADAPTORS - PROFEMUR R MODULAR NECKS B INSTRUMENTS CHAPTER 6 INDICATIONS AND WARNINGS 3

4 Preface Ordering Information Templates PFM4CL01E PFM4CL02E Surgical Technique Instruments APH00000 General Instruments Set APH02111 Profemur R Instruments Implants PRORKITA Tapered Stems PRORKITC HA prox. bodies 3251KITB Plasma prox. bodies 3251KITC Grit blasted prox. bodies PRORKITB Adaptors COCRKITA Modular Necks SUFIKITA Metal Heads CERAKITA Ceramic Heads DESIGN FEATURES OF THE PROFEMUR R REVISION SYSTEM Access to the hip joint is performed with the preferred surgical approach. All Components are fully interchangeable. Potential to obtain the best possible stability and adaptation of the system to the femoral anatomy. 8 Sizes X-small monoblock X-small modular Small STD 1-4 Large Tapered Profile Ellipsoidal Shape To minimize the potential for excessive stress on the bone when inserting the component Ti Alloy 3 Surface finishing options Roughened Ra = 8 µm Hydroxyapatite thickness = 100 ± 50 µm Plasma coating thickness = 500 ± 100 µm (providing 300 µm pressfit) Radial Cutting Splines Spline height increases distally Ti Alloy Ra - 5µm Morse Taper for distal connection Diameters (13 sizes) Different Sizes Curved Stems Short Straight (135mm) Medium (175mm) Long (215 mm) 4

5 Chapter 1 PRE OPERATIVE PLANNING Recommended Templating Procedure NOTE: Accurate preoperative templating requires good quality standardized radiographs of the pelvis and operative hip. When positioning the PROFEMUR R Hip System, it has been found advantageous to seat the implant at a depth that would allow a short neck with a medium head to approximate the height of the center of the femoral head. Seating the implant at this level will allow the most versatility from the modular head and necks during the trialing process. This position is predominantly determined through preoperative x-ray templating. When templating, appropriate proximal body size is determined first. The proximal body and distal stem templates should be used in conjunction to ensure accurate alignment. This is achieved when cortical contact is obtained on the medial, lateral, anterior and posterior sides of the implant. This will reduce the likelihood of stress shielding. Reference the implant position to a bone landmark to use as a guide for distal and proximal reaming to ensure the final implant will sit at the desired level. The proximal body must be templated both in lateral view and in A/P view. From this point, the appropriate distal stem is determined by finding the stem size that provides the most ideal canal fit. The anatomical curved medium and long distal stems can be adjusted to match the natural femoral shaft curvature, whilst the position of the proximal part allows separate consideration of antetorsion. The choice of modular necks and different head sizes further allows adjustment of leg length and geometry between stem and cup. 5

6 PRE OPERATIVE PLANNING Neck angle, neck length, and head length which most closely correspond to the patient s femoral head center can be estimated as well. The circles/squares found along the femoral neck axis represent the expected centers of rotation for the femoral head. For the ideal neck/head combination, the circle/square will align atop the previously determined center of rotation for the femoral head. Each circle represents the center of rotation for a modular short neck with the corresponding head option. Each square represents the center of rotation for a modular long neck with the corresponding head option. The circles/squares on the AP template of the stem illustrate the impact of choosing an 8 varus/ valgus neck relative to the neutral neck position. The lateral templates use circles/squares to compare the impact of choosing a neutral neck and necks with 8 or 15 anteversion/retroversion. Both the A/P and lateral views are needed to illustrate the impact of choosing an AR/VV neck because the combination necks provide multi-dimensional positioning. Each AR/ VV neck provides 4 anteversion/retroversion and 6 varus/valgus. The impact of each AR/VV option (1 or 2) depends upon which hip is being considered. Therefore, caution should be used to ensure that the appropriate combination is planned. Caution: Preoperative templating is intended for estimation purposes only. Final component size and position should be determined intraoperatively. NOTE: AR/VV necks can also affect neck position by 6 varus/valgus. 6

7 Chapter 2 SURGICAL TECHNIQUE Exposure of the artificial joint and primary implant removal Access to the hip joint is performed with the preferred surgical approach. Further dissection may be necessary to mobilize the proximal femur. Once sufficient space between the proximal femur and the pelvis has been created, the hip can be dislocated. The initial femoral implant can now be removed and the entrance to the femoral cavity can be exposed. Any bone cement, fibrous membrane, or excess tissue must be completely removed from the femoral canal. Canal Preparation The clean femoral canal may be initially prepared by utilizing the initial canal reamer (PPW36302) Figure 1 Figure 1 The initial canal reamer may also be used to evaluate and probe the femoral canal; assessing orientation and curvature of the femoral shaft. Prior to reaming the femoral canal, the medial aspect of the greater trochanter should be cleared of any overhanging bone to facilitate neutral alignment of the femoral reaming and proximal rasp instruments. The initial canal reamer features 3 marks on its shaft (SHORT; MEDIUM and LONG): they represent the total length of a STD proximal body coupled with a Short, Medium or Long stem, respectively. Initial Canal Reamer PPW

8 DISTAL BROACHING RECOMMENDED 5mm Per Side Press-Fit Stem Diameter Distal Broach 10mm - 11mm Size 10 12mm Size 11 13mm Size 12 14mm Size 13 15mm Size 14 16mm Size 15 17mm Size 16 mm Size 17 19mm Size 20mm Size 19 21mm Size 20 22mm Size 21 Distal broaches (to the tips of their teeth) are identical in size to the final implants. Customarily, the final stem implanted is one size larger than the last distal broach used to provide 0.5mm per side of spline bone penetration. (Table 1) For bowed stems, femoral bow orientation may be assessed with 9mm smooth curved trials before broaching. (APA ). Figure 2 Thread the distal broach/trial adaptor (PPW38158) to the selected trial stem. Attach the trial adaptor/trial stem assembly to the distal broach handle (PPW38094) and insert it in the femur. The trial stems feature graduated markings (0, 30 and 60 ) to help assess rotation. Table 1 Figure 2 Broach / Trial Adaptor PPW38158 Distal Broach Handle PPW38094 Trial Stems APA

9 Figure 3 The distal portion of the femur is prepared with the tapered distal broaches (APA ). In addition to serve as a broach, the distal broaches act as trials and are utilized to maintain alignment, estimate sizing, and evaluate femoral curvature. Thread the distal broach/ trial adaptor (PPW38158) to the broach. Assemble the adaptor/distal broach to the distal broach handle by aligning the broach locking collet slot with the peg on the distal broach handle. Lift the locking collet upward and insert the distal broach to the distal broach handle. Figure 3 Using a mallet with short, controlled strokes, begin broaching. Sequentially, increase the broach size while broaching. The distal broach handle has three marks Figure 3 that correspond to the proximal body heights (SM=Small, ST=Standard, L=Large). Insert the distal broach into the femur until the appropriate depth mark is aligned with the tip of the greater trochanter. For the x-small modular plasma sprayed proximal body, the distal broach handle should be sunk to 4mm below the SM depth mark. If the tip of the greater trochanter is not available as a landmark, an alternative such as the lesser trochanter should be used, and the distance between this point and the average center of rotation estimated preoperatively with the x-ray templates. Figure 4 Continue broaching untill the distal broach is fully seated. Once fully seated, lift the distal broach handle locking collet upward and disengage the distal broach handle from the distal broach, while the distal broach remains in the femur. Distal Broaches PA Broach / Trial Adaptor PPW

10 Junction Reamers (optional) After the distal broach is secured in the femur, junction reamers (APA ) matching the proximal body sizes (small through large) can be used to further clean and prepare the proximal femoral portion. Select the appropriate size junction reamer, matching the proximal body size and place it over the distal broach trial adaptor. Continue junction reaming until the junction reamer has bottomed out. Figure 5 & 6 After this step, care should be taken to verify that the distal broach adaptor (PPW38158) is securely tightened to the distal broach. Figure 5 Figure 6 Proximal Rasps The Profemur R system has 7 proximal rasps (x-small, small, standard 1 through 4, and large) (APA APA04262). Proximal rasping should be sequential in nature starting with the smallest size and gradually increasing until the appropriate size is found. Attach the proximal rasp handle (APA04240) to the appropriate proximal rasp by lifting the trigger upward and inserting the locking portion into the oval pocket of the rasp. Figure 7 Figure 7 NOTE: The ex-small monoblock proximal body does not have a dedicated proximal rasp. This implant is suggested to be used in femoral osteotomy procedures, where proximal bone preparation is not necessary. Junction Reamers APA Proximal Rasp Handle APA04240 Proximal Rasp APA

11 The 0 marks on the S and L scales on the proximal rasp handle approximate the head center of a medium head on a short or long neck, respectively. Proper depth of the proximal rasp is established by inserting the appropriate depth mark 1-3mm below the tip of the greater trochanter. Figure 8 The depth of the rasp toothed area of the proximal broach should approximate the final location of the roughened surface or plasma sprayed area of the final implant. Only the toothed area of the rasp corresponds to the implant size. Figure 8 Place the proximal rasp over the distal broach trial adaptor and utilizing light mallet blows, advance the proximal rasp. Figure 9 Attention should be directed toward positioning the rasp into the best bone for optimum fit and fixation. If proximal fit is not achieved, remove the proximal rasp, repeat with the next size and continue until the optimal rasp is found. The cannulated design allows proper positioning and alignment for the proximal bodies into the best available bone. Two proximal marks on the distal broach/ trial adaptor can be utilized to ensure proper proximal rasp depth insertion. Figure 9 Similar to the marks on the distal broach handle, SM, ST and L are marked on the broach/trial adaptor. However, on this instrument, SM and ST are aligned because the small proximal rasp is elongated, which compensates for the difference between SM and ST marks heights. 11

12 Trial Reduction Once rasping of the metaphyseal part is complete, remove the proximal rasp handle. The distal broach trial adaptor piece can now be removed, using the 3.5mm hex screw driver (PP275400, included in the APH00000 kit). Figure 10 Figure 11 A final check of anteversion can be made and the locking screw (PPW380077) can be inserted and tightened using the 3.5mm hex screw driver (PP275400). Figure 10 & 11 The locking screw is provided with a split washer to maintain a tight fit between the proximal rasps and distal broaches. Ensure that the split washer is separated before tightening to assure spring tension. Figure 12 Figure 12 At this time a trial reduction can be performed by using one of the two metal trial necks. Select the appropriate trial head corresponding the acetabular implant. The metal trial necks are designed in straight short and long options, only for preliminary evaluation (PA01662 or APA011664). Figure 13 & 14 WARNING: For the trial reduction, do not use the plastic trial necks with the broaches. Due to the broach design, the Profemur R metal trial necks have a different length than the plastic trial necks. Figure 13 Figure 14 The final trial reduction is accomplished with plastic trial necks on final implants. 3.5mm Hex Screwdriver PP Locking Screw PPW38077 Profemur R Metal Trial Necks APA

13 Extraction of the proximal rasp / distal broach assembly After trial reduction and adequate offset and leg length have been evaluated, remove the femoral head and metal trial neck components. Reinsert the proximal rasp handle (APA04240) and remove the proximal rasp and distal broach components. Figure 15 Before extraction of a bowed distal broach, ensure that the locking screw is tightly secured to maintain orientation of the distal broach and proximal rasp. Figure 15 A series of marks on the distal broach and proximal rasp correspond to similar markings on the matching proximal body and distal stem implants. By replicating the orientation of these marks on the final implants, reproduction of the correct bow orientation is possible. Figure 16 Figure 16 Proximal Rasp Handle APA

14 Implant Assembly and Insertion After the appropriate proximal and distal implant components have been selected, they must be connected via the morse taper. If implanting a bowed stem, align the appropriate marks on the proximal body and distal stem, ensuring the tapers of the proximal and distal components are clean. Place the two components together with hand pressure. Place the distal stem tip on a padded solid surface. Place a swap over the proximal body and apply firm mallet blows to engage the tapers. Figure 17 Figure 17 Assemble the stem impactor/extractor (PPW36292) into the proximal hole on the proximal femoral body. If a x-small monoblock proximal component is used, the x-small impactor/extractor (PPW38166) must be used. A rotation guide handle (PPW36294) is supplied and can be inserted into the femoral neck taper region of the proximal body if additional rotational control is required during impaction. Figure Figure Stem Impactor / Extractor PPW36292 x-small Impactor / Extractor PPW38166 Rotation Guide Handle PPW

15 Implant Assembly and Insertion After the implant is fully seated in its proper position, remove the impactor handle and insert the proximal distal locking screw to secure the taper between the distal stem and proximal body. Figure 19 Further flexibility with regard to the choice of distal stem length may be achieved with the addition of adaptors.. No trial components are available for these extensions implants. They are available in two different lengths (26mm and 52mm) and their usage with the selected proximal implant is detailed in Table 2. Figure 19 P/N Use with Prox. Part Length Diameter PPW00148 PPW00140 PPW00141 PPW00142 PPW00144 Ex-SMALL Monoblock Small / STD1 STD2 STD3/STD4/Large Small / STD / Large 26 mm 26 mm 26 mm 26 mm 52 mm Table 2 In case an extension is selected, the standard fixation screw packaged with the proximal body must be replaced with the one packaged with the selected extension adaptor. Sealing of the proximal component hole is now accomplished by assembling the hole plug to the proximal body. Figure 20 Figure 20 15

16 ADDENDUM Adjustment of the proximal body position If necessary, the proximal body position may be adjusted. First, replace the impactor/extractor instrument with the proximal-distal separator. (PPW38161 for x-small body or PPW38163, for the other proximal bodies) Figure 21 Secondly, insert the threaded separator rod (PPW38159) trough the hole in the impactor/extractor instrument. Attach the distal broach handle (PPW38094) to the separator rod and turn in a clockwise motion until the proximal and distal tapers are slightly separated. Figure 22 Figure 21 Remove the separator rod and the impactor/extractor instrument by turning it in a counter-clockwise motion, using the tommy bar (PPB31902) Reposition the proximal body in its proper orientation and continue impaction with the dedicated impactor/extractor instrument (PPW36292 or PPW38166). After the implant is fully seated in its proper position, remove the impactor/extractor instrument and insert the proximal distal locking screw. Sealing of the proximal component hole is now accomplished by assembling the hole plug to the proximal body. Figure 22 x-small Proximal - Distal Separator PPW38161 Proximal - Distal Separator PPW38163 Tommy Bar PPB31902 Threaded Separator Rod PPW

17 Trial Reduction Perform a final reduction using the trial necks and trial heads to reconfirm stability, range of motion and leg length. Select the appropriate Profemur trial neck (APA APA11154, included in APH00000) and trial head (APA02121-APA02154, included in APH00000 and APA ) and perform a trial reduction. Once a well-balanced hip has been created with a trial head and trial neck, you can introduce the final neck and head implant. Figure 23 & 24 Brief Summary of Neck Options Straight necks create a neutral neck axis (135 ) Varus necks decrease the inclination angle to 127 (neutral position is 135 ); the femoral head shifts medially and inferiorly; leg length is shortened; offset is increased. Valgus necks increase the inclination angle to 143 ; the femoral head shifts laterally and superiorly; leg length is increased; offset is decreased. Anteverted necks shift the femoral head anteriorly relative to the stem by 8 or 15. Retroverted necks shift the femoral head posteriorly relative to the stem by 8 or 15. Retroverted necks prove useful in hips with excess femoral anteversion such as DDH. Figure 23 Figure 24 AR/VV necks combine anteversion/retroversion and varus/valgus necks to offer a broad range of multidimensional head positions. Each AR/VV neck provides 4 of A/R and 6 of V/V. TIP: The choice of neck anteversion is based on intraoperative assessment of stability. The head/neck combination that allows maximal flexion/internal rotation and extension/external rotation without dislocation should be chosen. In case an x-small monoblock body is used, no trial reduction with modular necks is required. 17

18 Modular Neck Assembly To properly assemble and impact a Profemur Modular Neck, the following procedure is recommended: Step 1 Step 1. Suction any fluid from the stem implant pocket. Ensure that both the stem and neck are clean and dry prior to assembly. Step 2. Insert the oval end of the appropriate femoral neck implant into the femoral stem pocket. Step 2 Step 3. Position the leg such that the knee is supported by an assistant on the opposite side of the table. By resting the patient s knee against the mid-section of the assistant, this will provide counter-force against the mallet blows to ensure the impaction load transfer to the neck junction. Step 3 Step 4. Affix the femoral head to the neck. Using the head impactor instrument (PPR67702), strike the impactor with three very firm blows with a mallet to securely fix the head to the neck and stem. NOTE: If using a ceramic head, securely fix the neck into the stem by impaction, then place the head on the neck by hand, push and turn the head 0 to securely lock it in place. Step 4

19 Chapter 3 IMPLANT REMOVAL Femoral Head and Neck Removal Figure 25 If the removal of the implant is required due to revision or failure of the device, the surgeon should contact the manufacturer using the contact information located on the back cover of this surgical technique to receive instructions for returning the explanted device to the manufacturer for investigation. Figure 26 Figure 27 Femoral Head Removal The femoral head is removed by placing a plastic tipped femoral head impactor under the femoral head and applying mallet blows upward until the femoral head is removed. Figure 25 & 26 Femoral Neck Extraction Screw the femoral neck adaptor (APA09501) onto the femoral neck in a clockwise motion. The neck extractor (APA09500) goes over the top of the femoral neck and the adapter is captured by the adjustable hook. By squeezing the handle an extraction force is applied to the neck as the neck extractor pushes against the shoulder of the prosthesis. The extractor will accommodate any style and size of neck in combination with any style and size of prosthesis. Figure 27 & 28 Profemur Modular Necks Extractor Kit APH04600 Catalog# Description Figure 28 APA09500 Neck Extractor APA09501 Adaptor 12/14 for Neck Extractor APA09502 Wrench for Neck Extractor PP Hex Screwdriver PRNETR01 PROFEMUR Neck Extractor Tray or PKG Insert Instrument Cleaning 19

20 Removal Proximal Body Utilizing the screwdriver, remove the proximal body hole plug and loosen the proximal/distal locking screw. Screw the proximal-distal separator (PPW38161 for x-small body or PPW38163, dedicated to the small, standard and large proximal bodies) into the proximal hole on the proximal femoral body. Figure 29 Insert the threaded separating rod (PPW38159) trough the hole in the impaction handle. Attach the distal broach handle(ppw38094) to the separator rod and turn in a clockwise motion until the proximal and distal tapers are separated. Figure 30 Figure 29 Figure 30 Remove the separator rod and cannulated impactor handle by turning it in a counter-clockwise motion, using the tommy bar (PPB31902) Thread the impactor/extractor (PPW36292 or PPW38161 for x-small monoblock) into the proximal body. Using a mallet or slide hammer, extract the proximal body. Removal Distal Stem Thread the distal stem extractor (PPW36300) onto the distal stem. Using the slide hammer (PPW36296), extract the distal stem. Figure 31 & 32 Figure 31 Figure 32 x-small Proximal - Distal Separator PPW38161 Proximal - Distal Separator PPW38163 Tommy Bar PPB31902 Distal Broach Handle PPW38094 Distal Stem Extractor PPW36300 Slide Hammer PPW

21 Chapter 4 TECHNIQUE OVERVIEW STEP 1 X-ray templating of lateral and A/P view. STEP 2 Find canal axis STEP 3 Broach distally until cortical contact is achieved STEP 4 Proximally ream until appropriate mark is slightly below the greater trochanter. STEP 5 Broach up from the smallest size. Broach teeth approximate implant. STEP 6 Trial with metal necks to preliminarily determine neck length. STEP 7 Assemble implant on solid surface. STEP 8 Insert stem with stem impactor while using the ration guide handle for additional rotation control during impaction STEP 9 Insert stem locking screw (must be done before neck insertion). STEP 10 Trial using plastic necks and heads. STEP 11 Seat neck and head implants. STEP 12 Insert hole plug 21

22 Chapter 5 ORDERING INFORMATION A - Implants Proximal Bodies Proximal bodies Grit Blast 3251KITC Catalog # Description Size A B CØ PPW38058 PPW39102 PPW39104 PPW39106 PPW39108 PPW39110 PPW39112 Proximal body Sandblasted Proximal body Sandblasted Proximal body Sandblasted Proximal body Sandblasted Proximal body Sandblasted Proximal body Sandblasted Proximal body Sandblasted EX-Small (monoblock) Small Standard 1 Standard 2 Standard 3 Standard 4 Large , ,5 25 Figure 33 Figure 34 Proximal bodies Plasma Spray 3251KITB Catalog # Description Size A B CØ PPW38354 PPW38358 PPW38360 PPW38361 PPW38362 PPW38363 PPW38364 PPW38365 Proximal body Ti Plasma Spray Proximal body Ti Plasma Spray Proximal body Ti Plasma Spray Proximal body Ti Plasma Spray Proximal body Ti Plasma Spray Proximal body Ti Plasma Spray Proximal body Ti Plasma Spray Proximal body Ti Plasma Spray X-Small modular EX-Small monoblock Small Standard 1 Standard 2 Standard 3 Standard 4 Large , ,6,6,6 19,6 21,1 22,6 24,1 25,6 Proximal bodies HA Coated PRORKITC Catalog # Description Size A B CØ PPW39009 PPW39122 PPW39124 PPW39126 PPW39128 PPW39130 PPW39132 Proximal body HA Coated Proximal body HA Coated Proximal body HA Coated Proximal body HA Coated Proximal body HA Coated Proximal body HA Coated Proximal body HA Coated EX-Small monoblock Small Standard 1 Standard 2 Standard 3 Standard 4 Large , ,

23 ORDERING INFORMATION A - Implants Stems Tapered Splined Short (Straight) PRORKITA Figure 35 Catalog # Description Size A BØ CØ PPW38000 Tapered Stem Straight Size PPW38001 Tapered Stem Straight Size PPW38002 Tapered Stem Straight Size PPW38003 Tapered Stem Straight Size PPW38004 Tapered Stem Straight Size PPW38005 Tapered Stem Straight Size PPW38006 Tapered Stem Straight Size PPW38007 Tapered Stem Straight Size PPW38008 Tapered Stem Straight Size PPW38009 Tapered Stem Straight Size PPW38010 Tapered Stem Straight Size PPW38011 Tapered Stem Straight Size PPW38012 Tapered Stem Straight Size Tapered Splined Medium (Bowed) Tapered Splined Medium (Bowed) Catalog # Description Size A BØ CØ PPW38020 PPW38021 PPW38022 PPW38023 PPW38024 PPW38025 PPW38026 PPW38027 PPW38028 PPW38029 PPW38030 PPW38031 PPW38032 Size 10 Size 11 Size 12 Size 13 Size 14 Size 15 Size 16 Size 17 Size Size 19 Size 20 Size 21 Size Figure 36 23

24 ORDERING INFORMATION A - Implants Stems Tapered Splined Long (Bowed) Figure 37 Catalog # Description Size A BØ CØ PPW38040 PPW38041 PPW38042 PPW38043 PPW38044 PPW38045 PPW38046 PPW38047 PPW38048 PPW38049 PPW38050 PPW38051 PPW38052 Size 10 Size 11 Size 12 Size 13 Size 14 Size 15 Size 16 Size 17 Size Size 19 Size 20 Size 21 Size Adaptors Catalog # Description Length PPW00140 PPW00141 PPW00142 PPW00144 PPW00148 Length Adaptor Length Adaptor Length Adaptor Length Adaptor Length Adaptor

25 ORDERING INFORMATION A - Implants Modular Necks Profemur Modular Necks COCRKITA Catalog # PHA01202 PHAC1204 PHA01252 PHA01232 PHAC1234 PHA01242 PHAC1244 PHA01222 PHAC1224 PHA01212 PHAC1214 Modular Neck Straight Short (Ti Alloy) Straight Long (CoCr Alloy) Varus / Valgus 8 Short (Ti Alloy) Ante / Retro 8 Short (Ti Alloy) Ante / Retro 8 Long (CoCr Alloy) Ante / Retro 15 Short (Ti Alloy) Ante / Retro 15 Long (CoCr Alloy) Ante / Retro - Varus / Valgus 1 Short (Ti Alloy) Ante / Retro - Varus / Valgus 1 Long (CoCr Alloy) Ante / Retro - Varus / Valgus 2 Short (Ti Alloy) Ante / Retro - Varus / Valgus 2 Long (CoCr Alloy) Figure 38 25

26 ORDERING INFORMATION Profemur R Instruments APH02111 NOTE: Profemur R instruments APH02111 must be used with the General Instrument Set APH00000 Tray 1 PPR0TR01 Tray 2 PPR0TR02 Catalog No. Description PRR0TR01 PROFEMUR R General Tray 1 APA02112 APA02113 PPW36294 Trial Femoral Head 22mm M Trial Femoral Head 22mm L Rotation Guide Handle PPW38158 Distral Broach /Trial Adaptor Qty 5 PPW38094 PPW36302 APA04440 APA04430 APA01662 APA01664 PPW38165 APA04302 PROFEMUR Distal Broach Handle Initial Canal Reamer Tapered Trial Stem Long 215mm Tapered Trial Stem Medium 175mm Metal Trial Neck Neutral Short Metal Trial Neck Neutral Long Ruler 400mm Junction Reamer T Small APA04304 Junction Reamer Standard 1 APA04306 Junction Reamer Standard 2 APA04308 Junction Reamer Standard 3 APA04310 Junction Reamer Standard 4 APA04312 APA04248 APA04252 APA04254 APA04256 APA04258 APA04260 APA04262 Junction Reamer Large PROFEMUR Prox Body Rasp Xsmall PROFEMUR Prox Body Rasp Small PROFEMUR Prox Body Rasp STD1 PROFEMUR Prox Body Rasp STD2 PROFEMUR Prox Body Rasp STD3 PROFEMUR Prox Body Rasp STD4 PROFEMUR Prox Body Rasp Large PPW38077 Rasp Locking Screw Qty 2 PRR0TR02 PROFEMUR R General Tray 2 PPW38163 PROFEMUR R Prox/Distal Separator Small - STD - Large Proximal Bodies PPW38161 PPB31902 PPW36292 PPW38166 APA04240 PPW36300 PPW36296 PPW38159 PROFEMUR Prox/Distal Separator X-Small Proximal Body Tommy Bar Stem Impactor / Extractor Small - STD - Large Proximal Bodies Stem Impactor / Extractor X-Small Proximal Body New Proximal Rasp Handle Distal Stem Extractor Slide Hammer PROFEMUR Threaded Separator Rod (New) 26

27 ORDERING INFORMATION Profemur R Instruments APH02111 Catalog No. Description Catalog No. Description PRR0TR03 PROFEMUR R Tray 3 APA04340 Tapered Distal Broach Short Size 10 APA04342 Tapered Distal Broach Short Size 11 APA04344 Tapered Distal Broach Short Size 12 APA04346 Tapered Distal Broach Short Size 13 APA04348 Tapered Distal Broach Short Size 14 APA04350 Tapered Distal Broach Short Size 15 APA04352 Tapered Distal Broach Short Size 16 APA04354 Tapered Distal Broach Short Size 17 APA04356 Tapered Distal Broach Short Size APA04358 Tapered Distal Broach Short Size 19 APA04360 Tapered Distal Broach Short Size 20 APA04362 Tapered Distal Broach Short Size 21 APA04364 Tapered Distal Broach Short Size 22 PRR0TR04 PROFEMUR R Tray 4 APA04370 Tapered Distal Broach Medium Size 10 APA04372 Tapered Distal Broach Medium Size 11 APA04374 Tapered Distal Broach Medium Size 12 APA04376 Tapered Distal Broach Medium Size 13 APA04378 Tapered Distal Broach Medium Size 14 APA04380 Tapered Distal Broach Medium Size 15 APA04382 Tapered Distal Broach Medium Size 16 PRR0TR05 PROFEMUR R Tray 5 APA04384 Tapered Distal Broach Medium Size 17 APA04386 Tapered Distal Broach Medium Size APA04388 Tapered Distal Broach Medium Size 19 APA04390 Tapered Distal Broach Medium Size 20 APA04392 Tapered Distal Broach Medium Size 21 APA04394 Tapered Distal Broach Medium Size 22 PRR0TR06 PROFEMUR R Tray 6 APA04400 Tapered Distal Broach Long Size 10 APA04402 Tapered Distal Broach Long Size 11 APA04404 Tapered Distal Broach Long Size 12 APA04406 Tapered Distal Broach Long Size 13 APA04408 Tapered Distal Broach Long Size 14 APA04410 Tapered Distal Broach Long Size 15 APA04412 Tapered Distal Broach Long Size 16 PRR0TR07 PROFEMUR R Tray 7 APA04414 Tapered Distal Broach Long Size 17 APA04416 Tapered Distal Broach Long Size APA044 Tapered Distal Broach Long Size 19 APA04420 Tapered Distal Broach Long Size 20 APA04422 Tapered Distal Broach Long Size 21 APA04424 Tapered Distal Broach Long Size 22 PFM4CL01E PROFEMUR R X-Ray Template PFM4CL02E PROFEMUR R Extension X-Ray Template PKG Insert Instrument Cleaning Tray 3 PPR0TR03 Tray 4 PPR0TR04 Tray 5 PPR0TR05 Tray 6 PPR0TR06 Tray 7 PPR0TR07 27

28 General Instrument Kit APH00000 NOTE: The orientator handle of prosthesis (PPX028960) can be ordered as optional in place of stem guide impactor (APA01114), which is also optional. Catalog # Description PRGITR01 PROFEMUR General Tray 1 PPR67704 Initial Chisel ANCA-FIT PPW36294 Rotation Guide Handle PP Hex Screwdriver 3.5mm PPW38078 Rasp Handel PROFEMUR R APA00006 Tommy Bar For Cardan Spanner PPR67702 Head Impactor PPF60200 Final Stem Impactor TMF PPG30170 Extraction Ring APA11102 PROFEMUR Trial Neck Short Straight APA11104 PROFEMUR Trial Neck Long Straight APA11112 PROFEMUR Trial Neck Short A/R VAR/VAL 1 APA11114 PROFEMUR Trial Neck Long A/R VAR/VAL 1 APA11122 PROFEMUR Trial Neck Short A/R VAR/VAL 2 APA11124 PROFEMUR Trial Neck Long A/R VAR/VAL 2 APA11132 PROFEMUR Trial Neck Short A/R 80 APA11134 PROFEMUR Trial Neck Long A/R 80 APA11142 PROFEMUR Trial Neck Short A/R 150 APA11144 PROFEMUR Trial Neck Long A/R 150 APA11152 PROFEMUR Trial Neck Short VAR/VAL 80 APA11154 PROFEMUR Trial Neck Long VAR/VAL 80 APA11162 PROFEMUR Trial Neck Short VAR/VAL 150 APA11164 PROFEMUR Trial Neck Long VAR/VAL 150 APA02121 Femoral Head Trial 28mm S APA02122 Femoral Head Trial 28mm M APA02123 Femoral Head Trial 28mm L APA02124 Femoral Head Trial 28mm XL APA02125 Femoral Head Trial 28mm XXL APA02131 Femoral Head Trial 32mm S APA02132 Femoral Head Trial 32mm M APA02133 Femoral Head Trial 32mm L APA02134 Femoral Head Trial 32mm XL APA02142 Femoral Head Trial 36mm S APA02144 Femoral Head Trial 36mm M APA02146 Femoral Head Trial 36mm L APA02148 Femoral Head Trial 36mm XL APA02139 Femoral Head Trial 40mm S APA02140 Femoral Head Trial 40mm M APA02141 Femoral Head Trial 40mm L APA01114 Stem Guide Impactor Optional PPX Orientator Handle Optional or PKG Insert Instrument Cleaning 28

29 Chapter 6 INDICATIONS AND WARNINGS Intended Use MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. Indications for Use: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; and, 4) revision procedures where other treatments or devices have failed Rough grit blast surfaces and the hydroxyapetite and titanium plasma spray coatings applied to implant surfaces are intended for uncemented arthroplasty. Contraindications Patients should be warned of these contraindications. Contraindications include: 1) overt infection; 2) distant foci of infections (which may cause hematogenous spread to the implant site); 3) rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram; 4) skeletally immature patients (patient is less than 21 years of age at the time of surgery); 5) cases where there is inadequate neuromuscular status (e.g., prior paralysis, fusion and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable; 6) neuropathic joints; 7) hepatitis or HIV infection; 8) neurological or musculoskeletal disease that may adversely affect gait or weight-bearing. Additional contraindications for a metal-on-metal bearing include (Not available in U.S. or Canada): 1) Patients with known moderate to severe renal insufficiency; 2) Females of childbearing age are contraindicated due to the unknown effects of elevated levels of metal ions on the fetus. Compatible Modular Femoral Heads Stems and modular necks with the MicroPort 12/14 SLT Taper should only be used in combination with femoral heads with the MicroPort 12/14 SLT Taper. Cobalt chrome femoral heads with the MicroPort 12/14 SLT Taper are designed for use with cobalt-chromium-molybdenum, titanium alloy and ISO stainless steel (not available in the U.S. or Canada) femoral components with the MicroPort 12/14 SLT Taper. The neck/body component or neck/femoral stem should be changed only when clinically necessary. Refer to proper neck extraction technique in the surgical technique. Modular Necks Cobalt Chrome Modular Necks are not for use with the following devices: o Alumina (Biolox Forte) Ceramic Femoral Head (size 28mm Long) The potential long-term biological effects of metal wear debris and metal ion production are not known. Questions regarding carcinogenicity have been raised in literature; no studies have conclusive evidence that metal wear debris or metal ions are carcinogenic. IMPORTANT Prior to use of the system, the surgeon should refer to the product package insert for additional warnings, precautions, indications, contraindications and adverse effects. Instructions For Use package inserts are also available by contacting the manufacturer. Contact information can be found on the back of this Surgical Technique and the Instructions For Use package inserts are available on the website listed. The smaller sized femoral implants are intended for patients with narrower intramedullary femoral canals. The geometry of these implants is reduced to accomodate the anatomy of the narrower intramedullary femoral canal, which also decrease the fatique-strength and load-bearing characteristics of the implant. Other Modular Components (Femoral Head and Stems, Modular Necks and Proximal Body). Scratching of femoral heads, modular necks and proximal and distal stem tapers should be avoided. Repeated assembly and disassembly of these components could compromise the locking action of the taper joint. Prior to assembly, surgical debris must be cleaned from the interior of the female seat of the proximal body to ensure proper locking. Ensure components are firmly seated to prevent disassociation. The femoral head, neck taper of the femoral component, modular neck tapers, body taper, female seat of the proximal body must be clean and dry before assembly. Do not resterilize femoral prostheses with ceramic femoral heads seated on the stem. 29

30 MicroPort Orthopedics Inc Airline Road Arlington, TN USA ortho.microport.com EC REP MicroPort Orthopedics BV Hoogoorddreef BA Amsterdam The Netherlands The CE-Marking of Conformity is applied per catalog number and appears on the outer package label, if applicable. Trademarks and Registered marks of Microport Orthopedics Inc Microport Orthopedics Inc. All Rights Reserved FEB-16